Large Simple Trials and Knowledge Generation in a Learning Health System Workshop Summary (2013) / Chapter Skim
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1 Introduction
1 Introduction
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Although well-designed and well-implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers. Escalating costs, lengthy timelines, and the inability to regularly apply the evidence from clinical trials to broader populations are some of the challenges facing the U.S.
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Although challenges to the traditional RCT exist, a diverse portfolio of research methods, including innovative approaches to RCTs, is warranted to address evidence needs across the learning health care system -- for example, to inform medical providers treating patients with multiple conditions, researchers comparing the effectiveness of medical treatments, newly diagnosed patients exploring treatment options, and medical product developers pursuing new treatments for unmet medical needs. Innovative approaches include the use of streamlined designs, such as those used for LSTs; trials performed in settings that more closely mirror real-world settings, such as pragmatic trials; trials embedded in health care delivery settings, such as point-of-care trials; and trials that are modified while they are in progress, such as adaptive trials, among others.
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With the potential for such applicability and widespread use, LSTs present the opportunity, together with and as a complement to quasiexperimental methods, registries, and safety efforts, to improve the speed and practicality of knowledge generation, characteristics fundamental to a learning health care system. With the development of new technologies capable of acquiring, managing, linking, and analyzing large quantities of data, the potential for innovation in methods, including the ability to draw research insights from routine clinical care experiences more effectively, is growing.
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clinical trials enterprise that could benefit from increased implementation of simplified and streamlined clinical trial designs that produce generalizable results. In addition to drawing on a diverse array of perspectives on LST uptake, the workshop also explored infrastructure needs, the role of EHRs in LSTs, policies surrounding the enhanced use of LSTs, and the need for enhanced stakeholder engagement with health systems, clinicians, patients, and payers to successfully implement LSTs.
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. • Identify structural, cultural, and regulatory barriers hindering the development of an enhanced LST capacity and discuss needs and strategies in building public demand for and participation in LSTs; and • Suggest near-term strategies for accelerating progress in the uptake of LSTs in the United States.
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. ORGANIZATION OF THE SUMMARY This publication summarizes the proceedings of Large Simple Trials and Knowledge Generation in a Learning Health System, a joint workshop coordinated by the Roundtable and the Forum in 2012.
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The committee will steer development of the agenda for the workshop, including selection of speakers and discussants. Work shop content will explore the concepts of LST design; examples of successful LSTs; the relative advantages of LSTs (in terms of cost and the utility of the results) ; the infrastructure needed to build LST capacity as a routine function of care; the structural, cultural, and regulatory barriers hindering the development of such an LST capacity; building public demand for and participation in LSTs; and identifying near-term strategies for accelerating progress.
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Chapter 8 highlights the United Kingdom–based Randomized Evaluations of Accepted Choices in Treatment trials, underscoring lessons learned and best practices for LST investigators. Chapter 9 highlights the workshop participants' insights into strategies moving forward and summarizes the workshop's concluding discussion, in which many participants suggested potential strategies and priorities for accelerating progress in the uptake of LSTs in the United States.
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2012. News Report: Extraneous Data Col lected in Clinical Trials Cost Drug Developers $4 Billion to $6 Billion Annually.
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